BREAKING: Dermata's XYNGARI™ Phase 3 Trial Topline Data Meets All Primary Endpoints
Dermata Therapeutics (NASDAQ: DRMA) announced positive topline results from its first pivotal Phase 3 trial of XYNGARI™, a novel once-weekly topical treatment for moderate-to-severe acne. The STAR-1 trial met all three primary endpoints with statistically significant improvements compared to placebo after 12 weeks of treatment.
The randomized, double-blind study enrolled 520 patients aged 9 and older across the US and Latin America. XYNGARI™ demonstrated significant efficacy in Investigator Global Assessment (IGA) treatment success, inflammatory lesion count, and non-inflammatory lesion count. The treatment showed minimal adverse events with no serious events attributed to it.
Following these results, Dermata plans to initiate the second Phase 3 STAR-2 trial in the second half of 2025, followed by an open-label extension study. If successful, the Phase 3 program will support a new drug application with the FDA. The company is pursuing discussions with potential partners for XYNGARI™'s future rights.
Dermata Therapeutics (NASDAQ: DRMA) ha annunciato risultati positivi preliminari dal suo primo studio pivotale di Fase 3 di XYNGARI™, un nuovo trattamento topico settimanale per l'acne da moderata a grave. Lo studio STAR-1 ha raggiunto tutti e tre gli obiettivi primari con miglioramenti statisticamente significativi rispetto al placebo dopo 12 settimane di trattamento.
Lo studio randomizzato, in doppio cieco, ha arruolato 520 pazienti di età pari o superiore a 9 anni negli Stati Uniti e in America Latina. XYNGARI™ ha dimostrato un'efficacia significativa nel successo del trattamento secondo la Valutazione Globale dell'Investitore (IGA), nel conteggio delle lesioni infiammatorie e nel conteggio delle lesioni non infiammatorie. Il trattamento ha mostrato eventi avversi minimi, senza eventi gravi ad esso attribuiti.
In seguito a questi risultati, Dermata prevede di avviare il secondo studio di Fase 3 STAR-2 nella seconda metà del 2025, seguito da uno studio di estensione in aperto. Se avrà successo, il programma di Fase 3 supporterà una domanda di nuovo farmaco presso la FDA. L'azienda sta conducendo discussioni con potenziali partner per i diritti futuri di XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA) anunció resultados positivos preliminares de su primer ensayo pivotal de Fase 3 de XYNGARI™, un nuevo tratamiento tópico semanal para el acné moderado a grave. El ensayo STAR-1 cumplió con los tres objetivos primarios, mostrando mejoras estadísticamente significativas en comparación con el placebo después de 12 semanas de tratamiento.
El estudio, aleatorizado y doble ciego, incluyó a 520 pacientes de 9 años o más en los Estados Unidos y América Latina. XYNGARI™ demostró una eficacia significativa en el éxito del tratamiento según la Evaluación Global del Investigador (IGA), en el conteo de lesiones inflamatorias y en el conteo de lesiones no inflamatorias. El tratamiento mostró eventos adversos mínimos, sin eventos graves atribuidos a él.
Tras estos resultados, Dermata planea iniciar el segundo ensayo de Fase 3 STAR-2 en la segunda mitad de 2025, seguido de un estudio de extensión en abierto. Si tiene éxito, el programa de Fase 3 apoyará una solicitud de nuevo fármaco ante la FDA. La empresa está llevando a cabo conversaciones con posibles socios para los derechos futuros de XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA)는 중등도에서 중증 여드름을 위한 새로운 주간 국소 치료제인 XYNGARI™의 첫 번째 주요 3상 시험에서 긍정적인 최종 결과를 발표했습니다. STAR-1 시험은 치료 12주 후 위약에 비해 통계적으로 유의미한 개선을 보이며 세 가지 주요 목표를 모두 달성했습니다.
무작위 이중 맹검 연구에는 미국과 라틴 아메리카에서 9세 이상의 520명이 등록되었습니다. XYNGARI™는 연구자 글로벌 평가(IGA) 치료 성공, 염증성 병변 수 및 비염증성 병변 수에서 유의미한 효능을 보여주었습니다. 치료는 최소한의 부작용을 보였으며, 심각한 사건은 없었습니다.
이 결과를 바탕으로 Dermata는 2025년 하반기에 두 번째 3상 STAR-2 시험을 시작할 계획이며, 이후 공개 연장 연구를 진행할 예정입니다. 성공할 경우, 3상 프로그램은 FDA에 새 약물 신청을 지원할 것입니다. 회사는 XYNGARI™의 향후 권리를 위한 잠재적 파트너와의 논의를 진행하고 있습니다.
Dermata Therapeutics (NASDAQ: DRMA) a annoncé des résultats préliminaires positifs de son premier essai pivot de Phase 3 de XYNGARI™, un nouveau traitement topique hebdomadaire pour l'acné modérée à sévère. L'essai STAR-1 a atteint les trois objectifs principaux avec des améliorations statistiquement significatives par rapport au placebo après 12 semaines de traitement.
L'étude randomisée en double aveugle a inclus 520 patients âgés de 9 ans et plus aux États-Unis et en Amérique latine. XYNGARI™ a montré une efficacité significative dans le succès du traitement selon l'Évaluation Globale de l'Investisseur (IGA), le nombre de lésions inflammatoires et le nombre de lésions non inflammatoires. Le traitement a présenté des événements indésirables minimes, sans événements graves qui lui soient attribués.
Suite à ces résultats, Dermata prévoit de lancer le deuxième essai de Phase 3 STAR-2 dans la seconde moitié de 2025, suivi d'une étude d'extension en ouvert. Si cela réussit, le programme de Phase 3 soutiendra une demande de nouveau médicament auprès de la FDA. L'entreprise engage des discussions avec des partenaires potentiels pour les droits futurs de XYNGARI™.
Dermata Therapeutics (NASDAQ: DRMA) hat positive vorläufige Ergebnisse aus seiner ersten entscheidenden Phase-3-Studie zu XYNGARI™, einer neuartigen wöchentlichen topischen Behandlung für mittelschwere bis schwere Akne, bekannt gegeben. Die STAR-1-Studie erreichte alle drei primären Endpunkte mit statistisch signifikanten Verbesserungen im Vergleich zu Placebo nach 12 Wochen Behandlung.
Die randomisierte, doppelblinde Studie umfasste 520 Patienten im Alter von 9 Jahren und älter in den USA und Lateinamerika. XYNGARI™ zeigte eine signifikante Wirksamkeit bei der globalen Bewertung durch den Prüfer (IGA), der Anzahl entzündlicher Läsionen und der Anzahl nicht-entzündlicher Läsionen. Die Behandlung wies minimale unerwünschte Ereignisse auf, ohne dass ernsthafte Ereignisse darauf zurückzuführen waren.
Nach diesen Ergebnissen plant Dermata, in der zweiten Hälfte des Jahres 2025 die zweite Phase-3-Studie STAR-2 zu starten, gefolgt von einer offenen Verlängerungsstudie. Bei Erfolg wird das Phase-3-Programm eine neue Arzneimittelanmeldung bei der FDA unterstützen. Das Unternehmen führt Gespräche mit potenziellen Partnern über die zukünftigen Rechte an XYNGARI™.
- Met all primary endpoints in Phase 3 STAR-1 trial with statistically significant results
- First-ever once-weekly topical acne treatment showing clinical benefits in Phase 3
- Minimal adverse events with no serious safety concerns
- Large market opportunity with 30 million US acne patients annually
- Potential for improved patient compliance compared to daily treatments
- Second Phase 3 trial not yet started
- FDA approval still pending completion of full Phase 3 program
- Requires partnership for commercialization
Insights
Dermata's positive Phase 3 trial results for XYNGARI™ represent a significant clinical milestone with substantial commercial implications. Meeting all three primary endpoints with statistical significance in this pivotal trial dramatically de-risks the development program and validates their novel approach to acne treatment.
What stands out is XYNGARI's unique once-weekly application - a potentially game-changing differentiator in a market where patient compliance remains a persistent challenge. Current FDA-approved topical acne treatments require daily or twice-daily application, creating a clear competitive advantage for XYNGARI if approved.
The market opportunity is substantial with 30 million acne patients seeking treatment annually in the U.S. alone. For Dermata, a micro-cap company with
The path forward includes a second Phase 3 trial (STAR-2) planned for H2 2025, followed by an extension study. While substantial work remains before potential commercialization, this first Phase 3 success substantially increases the probability of eventual FDA approval. The risk-reward profile has improved dramatically with these results, as the first pivotal trial typically represents the highest clinical risk hurdle in late-stage development.
The successful Phase 3 results for XYNGARI™ could represent a meaningful advancement in acne treatment protocols. The moderate-to-severe acne population is particularly challenging to treat effectively, with many patients cycling through multiple therapies before finding adequate relief.
What's clinically impressive is XYNGARI achieved success across all three critical metrics: Investigator Global Assessment (IGA) treatment success, inflammatory lesion count reduction, and non-inflammatory lesion count reduction. This comprehensive efficacy profile suggests broad activity against different acne manifestations.
The once-weekly application addresses a fundamental issue in dermatological practice - patient adherence. Daily topical regimens show notoriously poor compliance rates, with studies suggesting 30-50% of patients fail to use products as prescribed. A weekly application could dramatically improve real-world effectiveness.
Safety data showing minimal treatment-related adverse events and no serious adverse events is equally important. Many effective acne treatments carry significant side effect profiles that limit their utilization, especially in younger patients.
If the second Phase 3 trial confirms these findings, XYNGARI would occupy a unique position in the treatment algorithm - potentially offering first-line efficacy with vastly improved convenience. For dermatologists managing large patient populations with variable compliance, this could become a valuable addition to the therapeutic armamentarium.
- XYNGARI™ achieved its primary endpoints, demonstrating highly statistically significant and clinically meaningful improvement in acne -
- XYNGARI™ is the first once-weekly topical product candidate to demonstrate clinical benefit in a Phase 3 clinical trial for moderate-to-severe acne -
- Over 30 million acne patients seek treatment in the
The XYNGARI™ Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial met all three primary endpoints by achieving a statistically significant difference when compared with placebo after 12 weeks of once weekly treatments with XYNGARI™.
"I believe having a once-weekly topical product with a strong efficacy and safety profile, like XYNGARI™, would be a great addition to a dermatologist's arsenal for treating acne," commented Dr. Sunil Dhawan, MD, FAAD, FACP, clinical investigator at the Center for Dermatology Clinical Research, Inc., a participating site in the STAR-1 trial. "All FDA approved topical acne products are required to be applied at least once or twice a day, which may reduce patient compliance, so I believe having a once-weekly topical acne product like XYNGARI™ could lead to improved patient compliance," concluded Dr. Dhawan.
"We are incredibly excited about these Phase 3 clinical trial results for XYNGARI™, which we believe reinforce its potential as a unique acne treatment, distinct from any existing product on the market," said Gerry Proehl, Chairman, President, and Chief Executive Officer of Dermata. "The highly statistically significant efficacy data not only confirms the results of our Phase 2b acne study but also strengthens our confidence about the upcoming XYNGARI™ Phase 3 STAR-2 trial, set to launch in the second half of 2025. With these positive Phase 3 clinical trial results, we are eager to advance discussions with potential partners interested in securing future rights to XYNGARI™," Mr. Proehl added.
XYNGARI™ Phase 3 STAR-1 Clinical Study Design
The XYNGARI™ Phase 3 STAR-1 clinical study evaluated the efficacy, safety, and tolerability of XYNGARI™ in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study which enrolled 520 patients with moderate-to-severe acne, ages 9 years and older in
XYNGARI™ Phase 3 STAR-1 Topline Efficacy Results
In the intent to treat analysis, Dermata saw statistically significant differences in IGA treatment success, inflammatory lesion count, and non-inflammatory lesion count at Week 12 (study end) when compared to placebo.
Investigator Global Assessment: Patients achieving a 2-point reduction AND score of 0 or 1 ("clear" or "almost clear")
Week 12 | |
XYNGARI™ (n=342) | 29.4 % |
Placebo (n=178) | 15.2 % |
p-value | p < 0.001 |
Mean change from baseline in inflammatory lesion count
Week 12 | |
XYNGARI™ (n=342) | -16.8 |
Placebo (n=178) | -13.1 |
p-value | p < 0.001 |
Mean change from baseline in non-inflammatory lesion count
Week 12 | |
XYNGARI™ (n=342) | -17.3 |
Placebo (n=178) | -12.4 |
p-value | p < 0.001 |
"We wish to thank the study subjects and investigators for their participation in our study, as we could not have had this success without them," states Christopher Nardo, Ph.D., Chief Development Officer of Dermata. "The clinical response observed in our XYNGARI™ Phase 3 STAR-1 trial gives us confidence that XYNGARI™, if approved, could alter the current treatment paradigm in acne by providing patients with a novel, natural, once-weekly treatment option with minimal side effects and potentially quicker time to treatment effect."
Based on these results, Dermata plans to initiate the second XYNAGRI™ Phase 3 STAR-2 trial in the second half of 2025, which will be followed by an open-label extension study. If the STAR-2 study produces positive results, the Phase 3 program will help support the filing of a new drug application with the
About XYNGARI™ (formerly DMT310)
XYNGARI™ is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. XYNGARI™ has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases.
About Acne Vulgaris
Over 30 million acne patients in the
About Dermata Therapeutics
Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. The Company's lead product candidate, XYNGARI™, is currently in Phase 3 and is the Company's first product candidate being developed from its Spongilla technology platform. XYNGARI™ is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI™ is being studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its XYNGARI™ product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic applications and medical skin diseases. Dermata is headquartered in
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but are not limited to, statements related to: expectations with regard to the potential market acceptance of any of the Company's product candidates; timing of trials and data events, including the initiation of a Phase 3 STAR-2 trial and extension study; expectations with regard to the timing and/or results or responses from meetings with regulatory bodies, including the FDA; expectations with regard to the timing of a New Drug Application with the FDA; the success, cost, funds available, and timing of its product candidate XYNGARI™ development activities and ongoing and planned clinical trials; and whether the results of XYNGARI™ will lead to future product development, partnerships, or approvals. These forward-looking statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com
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SOURCE Dermata Therapeutics, Inc.
FAQ
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